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NCT03030417 · ClinicalTrials.gov registry record · Phase 1
Indenoisoquinoline LMP744 in Adults With Relapsed Solid Tumors and Lymphomas
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT03030417: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT03030417 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03030417, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
Background: The new drug LMP744 (NSC 706744) damages deoxyribonucleic acid (DNA). This causes cell death. Researchers want to see if it can treat certain kinds of cancer. They want to understand how the drug works and how it affects the body. Objective: To test the safety of LMP744 and find out the dose of the drug that can be safely given to humans. Eligibility: Adults at least 18 years old who have metastatic solid tumors or lymphoma, which have progressed after other treatment. Design: Participants will be screened with: * Vital signs taken * Blood and urine tests * Heart tests * Scans or ultrasound Some participants will have a tumor sample taken 2 times. A small piece of tumor is removed by a small needle. A scan or ultrasound will guide the process. The study will be done in 28-day cycles. Each cycle, participants will get the study drug in a vein for 60 minutes once a day for 5 days. For day 1 of cycle 1, participants will be admitted to the clinic and have blood and urine taken several times. At the beginning of each cycle, participants will have a clinic visit and repeat some screening tests. They will also do this twice in the middle of cycle 1 and once in the middle of cycle 2. After participants stop taking the study drug, they will be followed for 30 days. They may give blood samples. They will be contacted by phone to see how they are doing....
Primary Outcome
Maximum tolerated dose (MTD) of LMP744 administered intravenously (IV) daily for 5 days (QD x 5) schedule in participants with refractory solid tumors and lymphomas. The MTD is the dose level at which no more than 1 in 6 participants experience dose-limiting toxicity (DLT), and the dose below that at which ≥ 2 (of ≤ 6) participants have DLT as a result of the drug. A DLT is Grade ≥3 non-hematologic toxicity except Grade 3 fatigue lasting ≤ 7 days. Grade 4 hematological toxicity if it meets the f
Interventions
- OTHER Olanzapine
- DRUG LMP744
- OTHER Ondansetron
- OTHER Lorazepam
- OTHER Diphenoxylate hydrocholoride (HCL) + Atropine Sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2017-02-27 |
| Est. Completion | 2023-10-12 |
| Phase | Phase 1 |
What the finished NCT03030417 record still lists
NCT03030417 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 5 interventions - of which Olanzapine is the first listed.
NCT03030417 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03030417 about?
NCT03030417 is a clinical study titled "Indenoisoquinoline LMP744 in Adults With Relapsed Solid Tumors and Lymphomas". Background: The new drug LMP744 (NSC 706744) damages deoxyribonucleic acid (DNA). This causes cell death. Researchers want to see if it can treat certain kinds of cancer. They want to understand how the drug works and how it affects the body. Objective: To test the safety of LMP744 and find out t...
What is the current status of trial NCT03030417?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2017-02-27. Estimated completion is 2023-10-12.
What interventions are being tested in trial NCT03030417?
The interventions under investigation include: Olanzapine (OTHER), LMP744 (DRUG), Ondansetron (OTHER), Lorazepam (OTHER), Diphenoxylate hydrocholoride (HCL) + Atropine Sulfate (OTHER).
Who is sponsoring clinical trial NCT03030417?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03030417's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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